Overactive bladder diagnostic apparatus and methods

Abstract

A method of diagnosing the risk that a subject has or has an increased risk of developing overactive bladder syndrome is described. The method includes detecting the levels of choline and/or acetylcholine in a biological sample from the subject, comparing the detected levels to reference values, and characterizing the subject as having an increased risk of having or developing overactive bladder syndrome if the choline and/or acetylcholine values are higher than the reference values. Kits for determining choline and/or acetylcholine levels in a subject, and methods of treating a subject for overactive bladder syndrome are also described.

What is claimed is: 
     
         1 . A method of diagnosing the risk that a subject has or has an increased risk of developing overactive bladder syndrome, comprising detecting the levels of choline and/or acetylcholine in a biological sample from the subject, comparing the detected levels to control values, and characterizing the subject as having an increased risk of having or developing overactive bladder syndrome if the choline and/or acetylcholine values are higher than the control values. 
     
     
         2 . The method of  claim 1 , wherein the subject is a human female. 
     
     
         3 . The method of  claim 2 , wherein the human female is post-menopausal. 
     
     
         4 . The method of  claim 1 , wherein the biological sample is urine. 
     
     
         5 . The method of  claim 1 , further comprising obtaining the biological sample from a subject. 
     
     
         6 . A method of treating a subject for overactive bladder syndrome, comprising the step of determining the level of acetylcholine in a biological sample from a subject having overactive bladder syndrome, and treating the subject with a therapeutically effective amount of an anticholinergic agent if the biological sample from the subject is has a higher acetylcholine level than a control value. 
     
     
         7 . The method of  claim 6 , wherein the subject is a human female. 
     
     
         8 . The method of  claim 7 , wherein the human female is post-menopausal. 
     
     
         9 . The method of  claim 6 , wherein the biological sample is urine. 
     
     
         10 . The method of  claim 6 , further comprising obtaining the biological sample from a subject. 
     
     
         11 . The method of  claim 6 , wherein the overactive bladder syndrome is treated using anti-cholinergic therapy. 
     
     
         12 . A kit for determining choline and/or acetylcholine levels in a subject, comprising a reagent for detecting the level of choline and/or acetylcholine in a biological sample obtained from the subject, and means for signaling the levels of choline and/or acetylcholine detected in the biological sample. 
     
     
         13 . The kit of  claim 12 , wherein the biological sample is urine. 
     
     
         14 . The kit of  claim 12 , wherein the kit provides a point-of-care diagnosis. 
     
     
         15 . The kit of  claim 12 , wherein the reagent for detecting the level of choline and/or acetylcholine is on a dip stick. 
     
     
         16 . The kit of  claim 12 , wherein the kit detects acetylcholine. 
     
     
         17 . The kit of  claim 12 , further comprising instructions for using the kit to treat or diagnose a subject for overactive bladder syndrome. 
     
     
         18 . The kit of  claim 12 , further comprising a package to hold the components of the kit.